EvoPAR-Prostate01
Research type
Research Study
Full title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305in Combination with Physician’s Choice New Hormonal Agents in Patients withHRRm and non-HRRm Metastatic Castration‑Sensitive Prostate Cancer (EvoPAR-Prostate01)
IRAS ID
1008354
Contact name
Sadia Akhtar
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Prostate cancer is the second most common cancer and the fifth most common cause of cancer-related death in men worldwide. There were 1,414,259 newly diagnosed patients in 2020 alone. Men who have metastatic castration-sensitive prostate cancer (mCSPC) receive androgen deprivation therapy (ADT) combined with a new hormonal agent (NHA) as standard of care treatment. Recent clinical studies have shown that treatment with a class of drugs called PARP inhibitors (in addition to ADT and NHA standard treatment) can lead to greater benefits for patients.
The goal of research study is to find out if the experimental PARP inhibitor, AZD5305, combined with new hormonal agents (NHAs) (abiraterone, darolutamide, or enzalutamide) and ADT works better for metastatic castration-sensitive prostate cancer (mCSPS) than NHAs and ADT alone.
1,800 participants from 26 countries will take part in this study. All participants will be males who are 18 years of age or older and have mCSPC that has spread to the bones and certain other parts of the body. Participants will all already be receiving treatment, or have previously had surgery, to lower their testosterone levels.
They will be randomly assigned to one of two treatment groups and will be receiving either AZD5305 with NHA or placebo with NHA until their cancer grows or spreads, or they stop treatment for another reason. The researchers will regularly review scans to keep track of how long they stay on treatment without their cancer growing or spreading.
Once treatment stops participants will be followed until the end of the study. The entire trial is expected to last about 7 years.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0373
Date of REC Opinion
6 Feb 2024
REC opinion
Further Information Favourable Opinion